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Completed Phase 3 Interventional Results available

Study of Diclofenac Capsules to Treat Osteoarthritis Pain

ClinicalTrials.gov ID: NCT01461369

Public ClinicalTrials.gov record NCT01461369. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 12, 2026, 12:11 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Parallel-Group, Efficacy and Safety Study of Diclofenac [Test] Capsules in Subjects With Osteoarthritis of the Knee or Hip

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to determine whether Diclofenac \[Test\] Capsules are safe and effective for the treatment of osteoarthritis pain of the hip or knee.

Study identification

NCT ID
NCT01461369
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Iroko Pharmaceuticals, LLC
Industry
Enrollment
305 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
40 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2011
Primary completion
Feb 29, 2012
Completion
Sep 30, 2012
Last update posted
May 25, 2014

2011 – 2012

United States locations

U.S. sites
40
U.S. states
20
U.S. cities
34
Facility City State ZIP Site status
Premier Research Group - Phoenix Phoenix Arizona 85027
Lynn Institute of the Ozarks Little Rock Arkansas 72205
Acri-Phase I, LLC Anaheim California 92801
Med Center Carmichael California 95608
Expresscare Clinical Research Colorado Springs Colorado 80909
Westside Center for Clinical Research Jacksonville Florida 32205
Jacksonville Center for Clinical Research Jacksonville Florida 32216
Well Pharma Medical Research, Corporation Miami Florida 33143
Peninsula Research, Inc Ormond Beach Florida 32174
Alliance Clinical Research Winter Park Florida 32792
Pinnacle Trials, Inc Atlanta Georgia 30329
Drug Studies America Marietta Georgia 30060
Clinical Investigation Specialists, Inc Gurnee Illinois 60031
Heartland Research Associates, LLC Newton Kansas 67114
Clinical Trials Technology Inc Prairie Village Kansas 66206
Professional Research Network of Kansas, LLC Wichita Kansas 67203
Community Research Crestview Hills Kentucky 41017
Quest Research Institute Bingham Farms Michigan 48025
Healthcare Research Florissant Missouri 63031
Sundance Clinical Research, LLC St Louis Missouri 63141
Heartland Clinical Research, Inc Omaha Nebraska 68134
Meridian Clinical Research Omaha Nebraska 68134
Office of Matthew Barton, MD Las Vegas Nevada 89106
Drug Trials America Hartsdale New York 10530
Clinical Study Center of Asheville, LLC Asheville North Carolina 28803
Triad Clinical Research Greensboro North Carolina 27408
Peters Medical Research High Point North Carolina 27262
Sterling Research Group, Ltd Cincinnati Ohio 45219
Community Research Cincinnati Ohio 45227
Community Research Cincinnati Ohio 45245
Sterling Research Group, Ltd Cincinnati Ohio 45246
Radiant Research, Inc Columbus Ohio 43212
Altoona Center for Clinical Research Duncansville Pennsylvania 16635
Radiant Research, Inc Anderson South Carolina 29621
Premier Research Group - Austin Austin Texas 78705
Clinical Investigations of Texas, LLC Plano Texas 75075
Quality Research Inc San Antonio Texas 78209
Progressive Clinical Research San Antonio Texas 78229
Charlottesville Medical Research Center, LLC Charlottesville Virginia 22911
Hypothetest, LLC Roanoke Virginia 24018

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01461369, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 25, 2014 · Synced Sep 12, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01461369 live on ClinicalTrials.gov.

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